Reference Standard Coordinator

Solutions Engineer- Public Sector

Senior DevOps Engineer

Project Management Engineer

Integrated Marketing Analyst –  Digital & Distribution, APAC

Buyer II

Process Mechanic – Sterile Filling & Packaging

Facility Mechanic

Facility Engineer

Process Equipment Engineer

Responsibilities: Sample Management <ul><li>Performs QC reference standard/chromatographic column receipt, processing, distribution for testing and storage.</li><li>Performs QC reference standard reconciliation and disposal.</li><li>Tracks inventory of reference standards in the lab.</li><li>Uses laboratory software for reference standard, chromatographic column management.</li><li>Verifies accuracy of labeling/documentation provided with reference standards.</li><li>Informs QC Coordinator if chemical or reference standard is expired for removal from laboratory area.</li><li>Coordinates, with lab management, in-house qualification of reference standards. Submit samples to the appropriate lab groups for testing.</li><li>Create and maintain reports including quality data trending, informational spreadsheets, laboratory log spreadsheets.</li><li>Compile a list of necessary laboratory supplies specifically reference standards, contacting vendors to obtain quotes.</li><li>Uses the purchasing system to procure reference standards and laboratory supplies.</li><li>Provide status updates to QC management and other departments regarding the status of reference standard inventory.</li><li>Maintain a safe work environment by following standards and procedures and complying with legal regulations.</li></ul> Lab Equipment <ul><li>Maintains, operates equipment and instruments supporting reference standard processing.</li><li>Provides general laboratory support such as routine instrument cleaning/preventative. maintenance, reference standard/sample receiving, chemical inventory, document filing and housekeeping.</li><li>Works with internal resources to maintain lab in an optimal state. Cleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.</li><li>Under close supervision, learns to troubleshoot basic instrument problems.</li></ul> Investigations <ul><li>Escalates any trends/events to the QC Lab Manager.</li><li>Escalates any reference standard documentation issues to the QC Lab Manager.</li><li>With guidance, participates in OOS/OOT/NOE and other investigations.</li><li>Assists, as and when needed, scientists working in the laboratory.</li><li>May assist in drafting, editing, and reviewing SOPs.</li></ul> Training <ul><li>Maintains assigned training records current and in-compliance.</li><li>May assist in the training of laboratory staff.</li></ul> Compliance <ul><li>Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting.</li><li>Documents accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.</li><li>Follows internal processes related to controlled substances.	continuous.</li></ul> Safety <ul><li>Follows EH&amp;S procedures to ensure a safe work environment.</li><li>Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS.</li></ul> Requirements: Education &amp; Experience <ul><li>College graduate, preferably in a Science related field.</li><li>Laboratory experience related to sample management preferred.</li></ul> Knowledge <ul><li>Basic knowledge of reference standard/sample management in a laboratory environment.</li><li>Some knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS.</li><li>Competency in Microsoft Office Suite.</li><li>Proficiency with computers.</li></ul> Skills &amp; Abilities <ul><li>Ability to display and analyze data in a logical manner.</li><li>Good verbal and written communication skills as well as good computer skills.</li><li>Attention to details and accurate record keeping.</li><li>Establish and maintain cooperative working relationships with others.</li><li>Solid organizational skills.</li><li>Ability to take initiative, set priorities and follow through on assignments.</li></ul> Physical Requirements	 <ul><li>Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals.</li><li>Must occasionally lift and/or move up to 15-25 lbs.</li><li>Ability to wear personal protective equipment, including respirators, gloves, etc.</li><li>Specific visions abilities are required by this job include close vision and color vision.</li><li>Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods.</li></ul>

Responsibilities: <ul><li>As a Solutions Engineer you will orchestrate involvement of all technical activities and resources, holding accountabilities for all opportunities within assigned account(s) and provide architectural perspective across the product portfolio, including software and services.</li><li>Serve as a technical sales consultant and trusted advisor to customers.</li><li>Orchestrate resources to ensure technical success throughout the sales lifecycle.</li><li>Collaborate closely with Account Managers and internal teams to deliver driven, customer-focused solutions.</li><li>Provide experienced mentorship on solution build, implementation, and differentiation.</li><li>Build positive relationships with engineering teams, business units, partners, and customers across multiple technology domains.</li></ul> Requirements <ul><li>Bachelor of Engineering degree or equivalent. with 12 years of presales experience in a technical position</li><li>Shown experience in solution selling with products and technologies.</li><li>Highly motivated, adaptable, and eager to learn new technologies.</li><li>Broad understanding of end-to-end architecture with expertise in areas such as enterprise networks, data center, or security.</li><li>Strong communication, whiteboarding, and presentation skills for effective customer engagement.</li><li>Skilled in value-based selling, handling objections, and possessing solid technical knowledge in networking, SDN, network security, and data center technologies.</li></ul>

Responsibilities: Cloud Infrastructure Design and Deployment: <ul><li>Architect, design, and implement scalable, reliable, and secure solutions on GCP.</li><li>Deploy and manage GCP services in both development and production environments, ensuring seamless integration with existing infrastructure.</li><li>Implement and manage core services such as BigQuery, Datafusion, Cloud Composer (Airflow), Cloud Storage, Data Fusion, Compute Engine, App Engine, Cloud Functions and more.</li></ul> Infrastructure as Code (IaC) and Automation: <ul><li>Develop and maintain infrastructure as code using Terraform or CLI scripts to automate provisioning and configuration of GCP resources.</li><li>Establish and document best practices for IaC to ensure consistent and efficient deployments across environments.</li></ul> DevOps and CI/CD Pipeline Development: <ul><li>Create and manage DevOps pipelines for automated build, test, and release management, integrating with tools such as Jenkins, GitLab CI/CD, or equivalent.</li><li>Work with development and operations teams to optimize deployment workflows, manage application dependencies, and improve delivery speed.</li></ul> Security and IAM Management: <ul><li>Handle user and service account management in Google Cloud IAM.</li><li>Set up and manage Secrets Manager and Cloud Key Management for secure storage of credentials and sensitive information.</li><li>Implement network and data security best practices to ensure compliance and security of cloud resources.</li></ul> Performance Monitoring and Optimization: <ul><li>Monitoring &amp; Security: Set up observability tools like Prometheus, Grafana, and integrate security tools (e.g., SonarQube, Trivy).</li><li>Networking &amp; Storage: Configure DNS, networking, and persistent storage solutions in Kubernetes.</li><li>Set up monitoring and logging (e.g., Cloud Monitoring, Cloud Logging, Error Reporting) to ensure systems perform optimally.</li><li>Troubleshoot and resolve issues related to cloud services and infrastructure as they arise.</li></ul> Workflow Orchestration: <ul><li>Orchestrate complex workflows using Argo Workflow Engine.</li><li>Containerization: Work extensively with Docker for containerization and image management.</li><li>Optimization: Troubleshoot and optimize containerized applications for performance and security.</li></ul> Requirements:﻿ <ul><li>Bachelors or masters degree in computer science, Information Technology, or a similar field</li><li>Must have 10 + years of extensive experience in designing, implementing, and maintaining applications on GCP and OpenShift</li><li>Comprehensive expertise in GCP services such as GKE, Cloudrun, Functions, Cloud SQL, Firestore, Firebase, Apigee, GCP App Engine, Gemini Code Assist, Vertex AI, Spanner, Memorystore, Service Mesh, and Cloud Monitoring</li><li>Solid understanding of cloud security best practices and experience in implementing security controls in GCP</li><li>Thorough understanding of cloud architecture principles and best practices</li><li>Experience with automation and configuration management tools like Terraform and a sound understanding of DevOps principles</li><li>Proven leadership skills and the ability to mentor and guide a technical team</li></ul>

Responsibilities: <ul><li>Manage the overall project process, controlling schedule and quality to ensure timely delivery.</li><li>Develop project plans and set milestones during the initial stage.</li><li>Track progress of tasks, hold meetings when necessary, and drive team members to complete tasks efficiently.</li><li>Coordinate with procurement, cost, logistics, production staff, and suppliers to ensure smooth execution of project activities.</li><li>Review project budgets and costs; conduct tooling strategy meetings.</li><li>Identify alternative resources to reduce costs and make directional decisions based on project requirements.</li><li>Assess potential risks and arrange preventive actions to avoid them.</li></ul> Requirements: <ul><li>5–8 years of solid project management experience, especially with APQP and&nbsp;</li><li>PPAP quality knowledge and related project process management.</li><li>Age: under 40 years old.</li><li>Education: Bachelor’s degree (full-time) in engineering, preferably mechanical engineering or related fields.</li><li>Degrees in business administration, language, or arts will not be considered.</li><li>Work location: Building G1, No. 88 Dongchang Road, Suzhou Industrial Park (Suzhou 2.5 Industrial Park).</li></ul>

Responsibilities: <ul><li>Work closely with TS Segment Mktg leadership to create a common vision for leveraging INDIRECT growth program &amp; distribution network and driving local for local approaches to advance segment &amp; BU goals.</li><li>Serve as a critical partner to BU Product &amp; Integrated Marketing and understand the key business drivers and levers for business success.</li><li>Initiative Digital &amp; Distribution marketing effective initiatives and align with key stakeholders &amp; partners to drive revenue results with marketing’s financial objectives &amp; budget.&nbsp;</li><li>Lead customer campaign effectiveness in both company APAC digital ecosystem and distribution networks, and push regional expansion, know-how and capability building.</li><li>Work closely with Product &amp; Integrated Marketing, Solutions Center, Channel teams, external agencies, distribution marketing staff, Key Account Managers, Global Account Managers, and Channel BU/Segment Marketing peers to develop messaging, tactics, and strategies that support strategic campaigns.</li><li>Drive awareness of relevant New Product Introductions (NPIs) through Channel Partners to ensure adoption and support revenue generation.</li><li>Manage and optimize agency relationships with a focus on media buying including paid search, programmatic, endemic, social media, CRM email.</li><li>For distribution efforts, collect and track Co-Op funded initiatives supporting TS Segment BUs, ensuring transparency and performance alignment.</li><li>Broader marketing metrics and success measurement will continue in collaboration with Channel Sales Enablement.</li><li>Perform customer analysis, segmenting customers into meaningful target groups and deploying precise marketing tactics based on actionable insights.</li><li>Increase lifetime value and reduce churn by engaging customers with the most targeted, relevant, and personalized content at each stage of the customer lifecycle.</li><li>Understand key customer segments and develop a linkage with distribution partner Voice of the Customer program outputs to refine messaging and customer campaigns.</li><li>Manage and motivate a team of Integrated Marketing Analyst, with an emphasis on talent development and engagement.&nbsp;</li><li>Influence Product Marketing who has ownership of project plans and successful completion of key BU marketing projects aligned with strategic business goals</li><li>Serve as liaison with regional Marketing in other BUs and other critical functions to drive global consistency, best practices and efficiencies related to Digital &amp; Distribution marketing processes and standards.</li><li>Partner with cross Segments teams to drive campaign effectiveness &amp; synergy of growth initiatives.</li><li>Partner with Digital team to build &amp; support initiatives in improving CX and business conversion.</li><li>Act as a role model for marketing, fostering, and promoting a mind-set and culture of customer-centric &amp; marketing excellence, and driving our clientOA.</li></ul> Requirements: <ul><li>BA – preferably advanced education and/or coursework, MBA degree preferred.</li><li>In-depth APAC marketing knowledge and experience with performance &amp; distribution marketing</li><li>5-10 years of integrated marketing experience in a B2B or technology company with a heavy focus on fragmented market development.</li><li>Proven expertise in B2B performance marketing, including Digital Marketing (SEM/SEO/Social), Media Planning/Buying, Campaign Development/Management and Analytics.</li><li>Strong business acumen, knowledge of the online medias, distribution partners, customer, competition, and issues impacting business coupled with the ability to use this information to shape communications and strategies.</li><li>Solid customer-centric customer journey design capability with excellent balance skillset of delivering quick-win performance and innovations for long-term.</li><li>Proven project management skills including conceptualization, driving alignment/change management, planning resources, managing deadlines and objectives, delivering analysis and recommendations.</li></ul>

Responsibilities: <ul><li>Support migration of Indirect Procurement processes from other Global countries to Alabang and prepare Indirect Procurement related process documentation (process maps and work instructions)</li><li>Become a Subject Matter Expert for Indirect Procurement related topics</li><li>Handle and resolve escalated procurement processing issues</li><li>Answer and resolve suppliers, stakeholders and AP queries to ensure timely resolution</li><li>Maintain supplier master data information in relevant systems</li><li>Ensure proper processing of PR’s and PO’s</li><li>Perform compliance checks</li><li>Expedite POs</li><li>Answer tickets (Procurement Helpdesk)</li><li>Manage invoice pricing issues</li><li>Create, maintain Info Record &amp; source lists</li><li>Spot Buy / Requisition Based Sourcing</li><li>Execute all procurement activities in-scope</li><li>Prepare and process eRFQ’s</li><li>Smaller Contract (value/complexity) negotiation &amp; execution</li><li>Execution of Projects assigned by Commodity Management</li><li>Desk Research and Price Comparison</li><li>Supplier training on tools</li><li>End-user Trainings</li><li>Savings reporting</li><li>Maintain communication with suppliers, stakeholders and other Indirect Procurement members</li><li>Execute periodically PR/PO audit queries or upon request KPI’s measurements</li><li>Ensure compliance with applicable client policies</li><li>Contribute to continuous improvement initiatives within the function, ensuring that improvements are incorporated in the work routine</li><li>Support robust compliance environment with applicable policies, procedures and processes</li><li>Build relationship with key stakeholders including suppliers</li><li>Support local BU owners, Function representatives or other Procurement team members to solve issues in a timely manner,</li><li>Build strong relationship with key stakeholders,</li><li>Attend team meetings and trainings as required.</li></ul> Requirements: <ul><li>Good Experience in Indirect Procurement (5+ years)</li><li>Previous experience in shared service environment</li><li>Good of MS office; very good Excel and other relevant tools for the function</li><li>SAP PR2, S/4</li><li>Good communication skills</li><li>Very good English language skills in speech and writing + additional language on top of Filipino preferred (Chinese, Spanish, German, French, etc.)</li><li>Diversified Industrial Products/Manufacturing industry experience preferred</li><li>Good command of other languages is a very important asset</li><li>Experience in a procurement shared service center supporting multiple countries / business units</li><li>Experience working for a Manufacturing company preferred</li><li>Good understanding of end-to-end S2P processes and associated technology platforms</li><li>Excellent organizational and analytical skills, solid problem solving and detail oriented</li><li>Strong communication skills</li><li>Ability to work with deadlines</li><li>Ability to work in culturally diverse teams with many levels of personnel.</li></ul>

Responsibilities: <ul><li>Perform preventive and corrective maintenance on sterile IV bag fillers, isolators, compounding equipment, sterilizers, component prep equipment, automated inspection machines, and secondary packaging systems.</li><li>Support equipment setup, calibration, and changeover in accordance with production schedules, maintenance plans, site SOPs, and cGMP requirements.</li><li>Assist in the installation, commissioning, and qualification of new sterile processing equipment, support equipment, and secondary packaging equipment.</li><li>Troubleshoot mechanical issues in real-time to minimize downtime while maintaining aseptic conditions and operator safety.</li><li>Ensure proper gowning, cleanliness, and contamination control practices when working in classified cleanroom environments.</li><li>Document all maintenance activities accurately in maintenance logs, work orders, and computerized maintenance management systems (CMMS).</li><li>Collaborate with Engineering, Manufacturing, and Quality to support equipment investigations, deviations, and continuous improvement initiatives.</li><li>Follow all safety procedures, including lockout/tagout, confined space, and PPE use; actively contribute to a culture of workplace safety and compliance.</li><li>Maintain spare parts inventory, tools, and maintenance supplies in an organized and audit-ready condition.</li><li>Participate in training and cross-functional activities to support plant startup and readiness for regulatory inspections.</li></ul> Requirements: <ul><li>High school diploma or technical certificate required, Associate’s degree in a mechanical or technical field preferred.</li><li>3+ years of experience as a mechanic or technician in a pharmaceutical, biotech, or sterile manufacturing environment.</li><li>Experience with isolator-based sterile filling equipment and cleanroom protocols is highly desirable.</li><li>Strong mechanical aptitude and experience with pumps, valves, conveyors, pneumatic systems, and packaging machinery.</li><li>Solid electrical and controls experience with automated systems, inspection machines, robotics, and camera systems highly preferred.</li><li>Working knowledge of cGMP, aseptic techniques, and safety regulations (OSHA, FDA, EU Annex 1).</li><li>Ability to read and interpret mechanical drawings, equipment manuals, and SOPs.</li><li>Familiarity with CMMS platforms and basic computer skills (e.g., Microsoft Office).</li><li>Self-motivated with strong attention to detail, problem-solving skills, and the ability to work independently or in a team.</li><li>Willingness to work flexible hours, including weekends or off-shifts during production or commissioning activities.</li></ul> Work Environment: <ul><li>Hands-on role in a cleanroom-based pharmaceutical manufacturing facility with strict safety and aseptic requirements.</li><li>Requires frequent gowning, standing, and work in confined or classified areas.</li><li>Fast-paced startup environment, requiring adaptability, initiative, and a collaborative mindset.</li><li>Occasional lifting of heavy tools or parts; use of ladders, lifts, and hand tools required.</li></ul>

Responsibilities: <ul><li>Perform preventive and corrective maintenance, troubleshooting, and repairs on facility infrastructure and critical utilities, including HVAC systems for cleanroom environment, compressed air and vacuum systems, clean utilities (WFI, purified water, clean steam), boilers, chillers, temperature control units, and effluent water treatment equipment.</li><li>Support equipment setup, calibration, qualification, and creation of maintenance plans of facility utilities and equipment.</li><li>Conduct round and inspection to monitor system performance and proactively address issues.</li><li>Ensure proper gowning, cleanliness, and contamination control practices when working in classified cleanroom environments.</li><li>Document all maintenance activities accurately in maintenance logs, work orders, and computerized maintenance management systems (CMMS).</li><li>Collaborate with Engineering, Manufacturing, and Quality to support equipment investigations, deviations, and continuous improvement initiatives.</li><li>Follow all safety procedures, including lockout/tagout, confined space, and PPE use; actively contribute to a culture of workplace safety and compliance.</li><li>Maintain spare parts inventory, tools, and maintenance supplies in an organized and audit-ready condition.</li><li>Participate in training and cross-functional activities to support plant startup and readiness for regulatory inspections.</li><li>Provide technical support of production activities during absence of production support team members or when bandwidth is insufficient.</li></ul> Requirements:﻿ <ul><li>High school diploma or technical certificate required, Associate’s degree in a mechanical or technical field preferred.</li><li>3+ years of experience as a mechanic or technician maintaining utilities or facilities infrastructure in a pharmaceutical, biotech, or regulated manufacturing environment.</li><li>Experience with pharmaceutical manufacturing equipment and cleanroom protocols is highly desirable.</li><li>Strong troubleshooting skills for mechanical, electrical, and control system issues.</li><li>Familiarity with building management systems (BMS) and alarm monitoring systems.</li><li>Solid electrical and controls experience with automated systems, inspection machines, robotics, and camera systems highly preferred.</li><li>Understanding of cGMP, contamination control, and safety regulations (OSHA, FDA, EU Annex 1).</li><li>Ability to read and interpret mechanical drawings, equipment manuals, and SOPs.</li><li>Familiarity with CMMS platforms and basic computer skills (e.g., Microsoft Office).</li><li>Self-motivated with strong attention to detail, problem-solving skills, and the ability to work independently or in a team.</li><li>Willingness to work flexible hours, including weekends or off-shifts during production or commissioning activities.</li></ul> Work Environment: <ul><li>Hands-on role in a regulated, sterile pharmaceutical manufacturing facility with strict safety and aseptic requirements.</li><li>Requires frequent gowning, standing, and work in confined or classified areas.</li><li>Fast-paced startup environment, requiring adaptability, initiative, and a collaborative mindset.</li><li>Occasional lifting of heavy tools or parts; use of ladders, lifts, and hand tools required.</li><li>Physical requirements include lifting climbing ladders, electrical troubleshooting, and working with hand and power tools</li></ul>

Role Description: <ul><li>The Facility Engineer will play a critical role in the greenfield design, construction, startup, and long-term operation of a state-of-the-art sterile injectable IV bag manufacturing facility. This role will lead the implementation and management of all facility infrastructure systems, including cleanrooms, HVAC, utilities, building automation, environmental monitoring, chemistry and microbiology lab systems, and energy management, ensuring full compliance with cGMP standards and regulatory expectations for sterile manufacturing.</li><li>The Facility Engineer will collaborate with cross-functional teams during construction, commissioning, qualification, and beyond, ensuring the facility infrastructure reliably supports sterile production, patient safety, and long-term business goals.</li></ul> Responsibilities: <ul><li>Lead the design review, specification development, and technical oversight of facility infrastructure systems including cleanrooms, HVAC, compressed air, chilled water, WFI, clean steam, and other critical utilities.</li><li>Develop and maintain facility engineering standards, equipment specifications, and technical documentation aligned to regulatory requirements and aseptic processing standards.</li><li>Oversee construction, installation, commissioning, and qualification of facility utilities and infrastructure systems, ensuring timely, compliant project execution.</li><li>Collaborate with Validation, Quality, and Operations teams to ensure proper facility qualification (IQ/OQ/PQ) and environmental monitoring readiness.</li><li>Promote and ensure adherence to safety protocols and safe work practices.</li><li>Perform risk assessments for engineering and maintenance activities.</li><li>Establish and manage preventative maintenance programs, calibration schedules, and facilities management SOPs to ensure optimal equipment performance and facility reliability.</li><li>Provide technical expertise in troubleshooting facility system deviations, non-conformances, and CAPAs, ensuring timely resolution and sustained compliance.</li><li>Partner with EHS, Operations, and Quality to ensure all facility systems meet safety, regulatory, and operational expectations.</li><li>Manage relationships with external engineering firms, contractors, and utility service providers to ensure effective delivery of construction and facility services. 11.	Support energy management, sustainability initiatives, and continuous improvement efforts to optimize facility operating costs and resource utilization.</li><li>Ensure ongoing regulatory inspection readiness and serve as SME for facility systems during audits and inspections.</li></ul> Requirements: Qualifications/Experience: <ul><li>Bachelor’s degree in mechanical, Electrical, Industrial, or Facilities Engineering.</li><li>3+ years of relevant experience in pharmaceutical or sterile manufacturing facility engineering.</li><li>Strong technical knowledge of facility infrastructure systems including HVAC for aseptic manufacturing, cleanrooms, and critical utilities.</li><li>Direct experience with greenfield facility construction, commissioning, and qualification highly desirable.</li><li>Solid understanding of FDA cGMP regulations, USP standards, and applicable environmental, health, and safety requirements.</li></ul> Skills/Competencies: <ul><li>Expertise Experience in facility system design, commissioning, and lifecycle maintenance.</li><li>Strong project management and contractor/vendor coordination capabilities.</li><li>Excellent problem-solving and root cause analysis skills.</li><li>Strong understanding of aseptic manufacturing facility requirements and environmental controls.</li><li>Effective communication and cross-functional collaboration skills.</li><li>High attention to detail, safety, and compliance.</li><li>Ability to thrive in a dynamic greenfield/startup environment.</li></ul>

Role Description: <ul><li>The Process Equipment Engineer will be a key technical leader responsible for the design, specification, procurement, installation, qualification, and ongoing reliability of process equipment for a greenfield sterile injectable IV bag manufacturing facility.</li><li>This role will play a critical part in ensuring that all manufacturing equipment all sterile manufacturing equipment are compliant with cGMP requirements, supports aseptic processing standards, and are capable of delivering high-quality product performance from day one of commercial operations. </li><li>Equipment includes sterile isolators, compounding, automated inspection, and secondary packaging for the production of sterile IV bags.</li><li>Working cross-functionally during the startup phase, the incumbent will drive equipment readiness, validation support, and serve as a technical subject matter expert (SME) for process equipment throughout the facility lifecycle.</li></ul> Responsibilities: <ul><li>Lead the specification, selection, and procurement of sterile injectable manufacturing process equipment, including isolator filling lines, formulation vessels, mixing systems inspection equipment, secondary packaging equipment, and associated support systems.</li><li>Develop user requirement specifications (URS), functional specifications (FS), and detailed equipment design documentation in compliance with regulatory and operational standards.</li><li>Manage equipment vendors, design reviews, factory acceptance testing (FAT), site acceptance testing (SAT), and oversee equipment delivery, installation, and commissioning.</li><li>Promote and ensure adherence to safety protocols and safe work practices.</li><li>Perform risk assessments for engineering and maintenance activities.</li><li>Collaborate with Validation, Quality, and Operations teams to support equipment qualification (IQ/OQ/PQ) and ensure all systems meet regulatory expectations for sterile manufacturing.</li><li>Establish preventative maintenance programs, spare parts inventories, and equipment lifecycle management plans to ensure long-term equipment reliability and availability.</li><li>Provide technical expertise during troubleshooting, deviations, and investigations related to process equipment performance, ensuring rapid resolution of issues.</li><li>Partner with Manufacturing and Quality teams to optimize equipment performance, drive continuous improvement initiatives, and support ongoing process optimization.</li><li>Identify and implement process improvements to enhance operational safety, efficiency, and reliability.</li><li>Support development of SOPs, equipment manuals, and operator training programs to ensure safe and compliant operation of process equipment.</li><li>Ensure equipment designs fully comply with cGMP, FDA, OSHA, and all applicable regulatory and safety standards.</li><li>Contribute to capital project planning, budgeting, and project execution related to new equipment or facility expansions.</li><li>Ensure ongoing regulatory inspection readiness and serve as SME for process systems during audits and inspections.</li></ul> Requirements: <ul><li>Bachelor’s degree in mechanical engineering, Chemical Engineering, Industrial Engineering, or related field.</li><li>3+ years of experience in pharmaceutical process equipment engineering, with significant exposure to sterile injectable manufacturing strongly preferred.</li><li>Direct experience with design, procurement, and qualification of aseptic manufacturing equipment and cleanroom environments.</li><li>Solid understanding of cGMP regulations, FDA/EMA expectations, and engineering best practices for sterile operations.</li><li>Experience working in greenfield or major facility expansion projects highly desirable.</li></ul> Skills/Competencies: <ul><li>Strong technical knowledge of process equipment design, aseptic manufacturing, and utility systems.</li><li>Proven project management skills with ability to handle complex, cross-functional projects.</li><li>Excellent problem-solving abilities and root cause investigation experience.</li><li>Effective communication and vendor management skills.</li><li>Ability to work independently in a fast-paced, startup-like environment.</li><li>Strong teamwork, collaboration, and continuous improvement mindset.</li><li>High attention to detail with strong commitment to safety, compliance, and product quality.</li></ul>

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56 solid works Jobs found

Reference Standard Coordinator

Solutions Engineer- Public Sector

Senior DevOps Engineer

Project Management Engineer

Integrated Marketing Analyst – Digital & Distribution, APAC

Buyer II

Process Mechanic – Sterile Filling & Packaging

Facility Mechanic

Facility Engineer

Process Equipment Engineer

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Skills

Industry

Location

Jobtitle

56 solid works Jobs found

Reference Standard Coordinator

Solutions Engineer- Public Sector

Senior DevOps Engineer

Project Management Engineer

Integrated Marketing Analyst – Digital & Distribution, APAC

Buyer II

Process Mechanic – Sterile Filling & Packaging

Facility Mechanic

Facility Engineer

Process Equipment Engineer

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

EMPLOYER

TALENT

COMPANY

Contact Us

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WhiteCrow
WhiteCrow is on a mission to connect companies with the best talent across the globe.